Chronic Kidney DiseaseNCT07854275
Biomarkers, Abdominal Muscle, and Frailty in CKD
An observational study of Chronic Kidney Disease and Abdominal Muscles/Ultrasonography, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
In chronic kidney disease (CKD), inflammation and oxidative stress are important processes that may be associated with the development of muscle loss and frailty. The aim of this study is to investigate the relationships between serum MCP-1, total antioxidant status (TAS), and total oxidant status (TOS)-markers of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease, Abdominal Muscles/Ultrasonography, Frailty
- What is being tested?
- total antioxidant status, total oxidant status and monocyte chemotactic protein-1
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2025to 1 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18-70 years stage 3-5 CKD
Who may be able to join
- the ages of 18 and 70
- have been diagnosed with stage 3, 4, or 5 chronic kidney disease (CKD) for at least 6 months
- have been receiving stable medical treatment for the past 6 months
- be in a clinically stable condition
- have no cognitive impairment
- be literate; and have no vision or hearing problems that would prevent the administration of the scales
Who cannot join
- Patients undergoing dialysis
- those with acute infection
- malignancy
- uncontrolled hypertension
- severe heart failure
- a history of neurological disease (stroke, cerebral hemorrhage)
Show all 10Show fewer
- severe anemia (Hb < 7)
- pregnant women
- patients with immunodeficiency
- those taking steroids; and patients with chronic inflammatory diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association of Total Oxidant/Antioxidant Capacity and MCP-1 Markers With Abdominal Muscle Thickness and Frailty in Patients With Stage 3-5 Chronic Kidney Disease
In chronic kidney disease (CKD), inflammation and oxidative stress are important processes that may be associated with the development of muscle loss and frailty. The aim of this study is to investigate the relationships between serum MCP-1, total antioxidant status (TAS), and total oxidant status (TOS)-markers of inflammation and oxidative stress-and abdominal muscle thickness and frailty, as assessed by ultrasound, in stage 3-5 CKD patients not receiving dialysis. In addition, the study aims to assess participants' physical performance, kinesiophobia, and quality of life and to examine these characteristics according to CKD stages.
Read the detailed description
Chronic kidney disease (CKD) is a chronic condition associated not only with a decline in renal function but also with systemic effects such as inflammation, oxidative stress, muscle loss, and impaired physical function. It is hypothesized that the chronic inflammation and oxidative stress developing during the course of the disease contribute to alterations in skeletal muscle structure and function. However, data regarding the relationship of these processes with abdominal muscles in patients with advanced-stage CKD who are not undergoing dialysis are limited.
This cross-sectional study aims to evaluate the associations between inflammatory and oxidative stress markers and abdominal muscle thickness and frailty in patients with stage 3-5 CKD not receiving dialysis. Serum monocyte chemoattractant protein-1 (MCP-1) is used as an inflammatory marker, while total antioxidant status (TAS), total oxidant status (TOS), and the oxidative stress index (OSI)-calculated from these values-are used to assess oxidative/antioxidative status.
To assess abdominal muscles, the thicknesses of the rectus abdominis, external oblique, internal oblique, and transversus abdominis muscles are measured via ultrasonography. Frailty is assessed using the FRAIL scale and the Clinical Frailty Scale. The study also aims to examine the clinical and functional characteristics across different stages of CKD by evaluating participants' physical performance, kinesiophobia, and kidney disease-specific quality of life. This study aims to simultaneously evaluate the associations of inflammation and oxidative stress markers with abdominal muscle thickness and frailty in the same patient group, and to conduct a more comprehensive examination of muscle and functional impairment in pre-dialysis patients with stage 3-5 CKD.
- Being tested
- total antioxidant status, total oxidant status, monocyte chemotactic protein-1, ultrasonography muscle, FRAIL scale
- Keywords
- abdominal muscle, chronic kidney disease, monocyte chemoattractant protein-1, total antioxidant status, total oxidant status
- Medical subject headings
- Renal Insufficiency, Chronic, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total antioxidant statusOther
total antioxidant status
total oxidant statusOther
total oxidant status
monocyte chemotactic protein-1Other
monocyte chemotactic protein-1
ultrasonography muscleOther
abdominal muscles
FRAIL scaleOther
frailty
clinical frailty scaleOther
frailty
tampa scaleOther
kinesiophobia
| Study group | Role | What they receive |
|---|---|---|
| stage 3 | chronic kidney disease stage 3 Receives: Other: total antioxidant status; Other: total oxidant status; Other: monocyte chemotactic protein-1; Other: ultrasonography muscle; Other: FRAIL scale; Other: clinical frailty scale; Other: tampa scale | |
| stage 4 | chronic kidney disease stage 4 Receives: Other: total antioxidant status; Other: total oxidant status; Other: monocyte chemotactic protein-1; Other: ultrasonography muscle; Other: FRAIL scale; Other: clinical frailty scale; Other: tampa scale | |
| stage 5 | chronic kidney disease stage 5 Receives: Other: total antioxidant status; Other: total oxidant status; Other: monocyte chemotactic protein-1; Other: ultrasonography muscle; Other: FRAIL scale; Other: clinical frailty scale; Other: tampa scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography measurements
abdominal muscles
Measured: 20 week
Frailty
FRAIL scale: The FRAIL scale consists of 5 items, each scored on a scale of 0-1. The total score ranges from 0 to 5. Based on the total score, 0 is classified as robust/non-frail, 1-2 as prefrail, and 3 as frail.
Measured: 20 weeks
Frailty 2
clinic frailty scale:Participants' levels of frailty were assessed using the CFS, a scale with established Turkish validity and reliability. The CFS is a scale rated on a scale of 1 to 9, taking into account an individual's independence in activities of daily living and need for assistance. Higher numbers indicate a higher level of frailty.
Measured: 20 weeks
total antioxidant status
total antioxidant status :TAS levels were measured using commercial kits (Rel Assay Diagnostics, Turkey). Results were recorded in mmol Trolox equivalent/L.
Measured: 20 weeks
total oxidant status
total oxidant status : TOS levels were measured using commercial kits (Rel Assay Diagnostics, Turkey). Results were recorded in μmol H₂O₂ equivalent/L.
Measured: 20 week
Secondary outcomes (1)
kinesiophobia
tampa scale: This is a Turkish-language measure with established validity and reliability that we use to assess participants' fears related to physical activity and movement. The scale consists of 17 items, each rated on a scale of 1 to 4. A higher score indicates a greater level of fear of movement.
Measured: 20 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start15 Jan 2025
- Primary completion15 May 2025
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Handan Elif Nur BAYRAKTAR, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854275
- Sponsor's protocol ID
- Samsun-PMR-DRHENY-02
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yousefzadeh MJ, Schafer MJ, Noren Hooten N, Atkinson EJ, Evans MK, Baker DJ, Quarles EK, Robbins PD, Ladiges WC, LeBrasseur NK, Niedernhofer LJ. Circulating levels of monocyte chemoattractant protein-1 as a potential measure of biological age in mice and frailty in humans. Aging Cell. 2018 Apr;17(2):e12706. doi: 10.1111/acel.12706. Epub 2017 Dec 31.
PubMed 29290100Beyer I, Njemini R, Bautmans I, Demanet C, Bergmann P, Mets T. Inflammation-related muscle weakness and fatigue in geriatric patients. Exp Gerontol. 2012 Jan;47(1):52-9. doi: 10.1016/j.exger.2011.10.005. Epub 2011 Oct 18.
PubMed 22032874Schettini IVG, Faria DV, Nogueira LS, Otoni A, Silva ACSE, Rios DRA. Renin angiotensin system molecules and chemokine (C-C motif) ligand 2 (CCL2) in chronic kidney disease patients. J Bras Nefrol. 2022 Jan-Mar;44(1):19-25. doi: 10.1590/2175-8239-JBN-2021-0030.
PubMed 34251390Watanabe H, Enoki Y, Maruyama T. Sarcopenia in Chronic Kidney Disease: Factors, Mechanisms, and Therapeutic Interventions. Biol Pharm Bull. 2019;42(9):1437-1445. doi: 10.1248/bpb.b19-00513.
PubMed 31474705Chao CT, Kovesdy CP, Merchant RA. Sarcopenia, sarcopenic obesity, and frailty in individuals with chronic kidney disease: a comprehensive review. Kidney Res Clin Pract. 2026 Mar;45(2):174-188. doi: 10.23876/j.krcp.24.207. Epub 2025 Jan 21.
PubMed 39973319Wang XH, Mitch WE. Mechanisms of muscle wasting in chronic kidney disease. Nat Rev Nephrol. 2014 Sep;10(9):504-16. doi: 10.1038/nrneph.2014.112. Epub 2014 Jul 1.
PubMed 24981816Bello AK, Alrukhaimi M, Ashuntantang GE, Basnet S, Rotter RC, Douthat WG, Kazancioglu R, Kottgen A, Nangaku M, Powe NR, White SL, Wheeler DC, Moe O. Complications of chronic kidney disease: current state, knowledge gaps, and strategy for action. Kidney Int Suppl (2011). 2017 Oct;7(2):122-129. doi: 10.1016/j.kisu.2017.07.007. Epub 2017 Sep 20.
PubMed 30675426
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Total Oxidant/Antioxidant Capacity and MCP-1 Markers With Abdominal Muscle Thickness and Frailty in Patients With Stage 3-5 Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07854275
- Acronym / sponsor ID
- Samsun-PMR-DRHENY-02
- Keywords
- abdominal muscle, chronic kidney disease, monocyte chemoattractant protein-1, total antioxidant status, total oxidant status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In chronic kidney disease (CKD), inflammation and oxidative stress are important processes that may be associated with the development of muscle loss and frailty. The aim of this study is to investigate the relationships between serum MCP-1, total antioxidant status (TAS), and total oxidant status (TOS)-markers of inflammation and oxidative stress-and abdominal muscle thickness and frailty, as assessed by ultrasound, in stage 3-5 CKD patients not receiving dialysis. In addition, the study aims to assess participants' physical performance, kinesiophobia, and quality of life and to examine these characteristics according to CKD stages.
Detailed description
Chronic kidney disease (CKD) is a chronic condition associated not only with a decline in renal function but also with systemic effects such as inflammation, oxidative stress, muscle loss, and impaired physical function. It is hypothesized that the chronic inflammation and oxidative stress developing during the course of the disease contribute to alterations in skeletal muscle structure and function. However, data regarding the relationship of these processes with abdominal muscles in patients with advanced-stage CKD who are not undergoing dialysis are limited.
This cross-sectional study aims to evaluate the associations between inflammatory and oxidative stress markers and abdominal muscle thickness and frailty in patients with stage 3-5 CKD not receiving dialysis. Serum monocyte chemoattractant protein-1 (MCP-1) is used as an inflammatory marker, while total antioxidant status (TAS), total oxidant status (TOS), and the oxidative stress index (OSI)-calculated from these values-are used to assess oxidative/antioxidative status.
To assess abdominal muscles, the thicknesses of the rectus abdominis, external oblique, internal oblique, and transversus abdominis muscles are measured via ultrasonography. Frailty is assessed using the FRAIL scale and the Clinical Frailty Scale. The study also aims to examine the clinical and functional characteristics across different stages of CKD by evaluating participants' physical performance, kinesiophobia, and kidney disease-specific quality of life. This study aims to simultaneously evaluate the associations of inflammation and oxidative stress markers with abdominal muscle thickness and frailty in the same patient group, and to conduct a more comprehensive examination of muscle and functional impairment in pre-dialysis patients with stage 3-5 CKD.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| stage 3 | – | Other: total antioxidant status, Other: total oxidant status, Other: monocyte chemotactic protein-1, Other: ultrasonography muscle, Other: FRAIL scale, Other: clinical frailty scale, Other: tampa scalechronic kidney disease stage 3 |
| stage 4 | – | Other: total antioxidant status, Other: total oxidant status, Other: monocyte chemotactic protein-1, Other: ultrasonography muscle, Other: FRAIL scale, Other: clinical frailty scale, Other: tampa scalechronic kidney disease stage 4 |
| stage 5 | – | Other: total antioxidant status, Other: total oxidant status, Other: monocyte chemotactic protein-1, Other: ultrasonography muscle, Other: FRAIL scale, Other: clinical frailty scale, Other: tampa scalechronic kidney disease stage 5 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18-70 years stage 3-5 CKD
Key inclusion criteria (6 listed)
- the ages of 18 and 70
- have been diagnosed with stage 3, 4, or 5 chronic kidney disease (CKD) for at least 6 months
- have been receiving stable medical treatment for the past 6 months
- be in a clinically stable condition
- have no cognitive impairment
Key exclusion criteria (10 listed)
- Patients undergoing dialysis
- those with acute infection
- malignancy
- uncontrolled hypertension
- severe heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total antioxidant statustotal antioxidant status | Other | stage 3, stage 4, stage 5 |
| total oxidant statustotal oxidant status | Other | stage 3, stage 4, stage 5 |
| monocyte chemotactic protein-1monocyte chemotactic protein-1 | Other | stage 3, stage 4, stage 5 |
| ultrasonography muscleabdominal muscles | Other | stage 3, stage 4, stage 5 |
| FRAIL scalefrailty | Other | stage 3, stage 4, stage 5 |
| clinical frailty scalefrailty | Other | stage 3, stage 4, stage 5 |
| tampa scalekinesiophobia | Other | stage 3, stage 4, stage 5 |
Primary outcome
Ultrasonography measurements
Time frame: 20 week
abdominal muscles
Frailty
Time frame: 20 weeks
FRAIL scale: The FRAIL scale consists of 5 items, each scored on a scale of 0-1. The total score ranges from 0 to 5. Based on the total score, 0 is classified as robust/non-frail, 1-2 as prefrail, and 3 as frail.
Frailty 2
Time frame: 20 weeks
clinic frailty scale:Participants' levels of frailty were assessed using the CFS, a scale with established Turkish validity and reliability. The CFS is a scale rated on a scale of 1 to 9, taking into account an individual's independence in activities of daily living and need for assistance. Higher numbers indicate a higher level of frailty.
total antioxidant status
Time frame: 20 weeks
total antioxidant status :TAS levels were measured using commercial kits (Rel Assay Diagnostics, Turkey). Results were recorded in mmol Trolox equivalent/L.
total oxidant status
Time frame: 20 week
total oxidant status : TOS levels were measured using commercial kits (Rel Assay Diagnostics, Turkey). Results were recorded in μmol H₂O₂ equivalent/L.
1 secondary outcome
kinesiophobia
Time frame: 20 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 29290100Yousefzadeh MJ, Schafer MJ, Noren Hooten N, Atkinson EJ, Evans MK, Baker DJ, Quarles EK, Robbins PD, Ladiges WC, LeBrasseur NK, Niedernhofer LJ. Circulating levels of monocyte chemoattractant protein-1 as a potential measure of biological age in mice and frailty in humans. Aging Cell. 2018 Apr;17(2):e12706. doi: 10.1111/acel.12706. Epub 2017 Dec 31.
- Background: PubMed 22032874Beyer I, Njemini R, Bautmans I, Demanet C, Bergmann P, Mets T. Inflammation-related muscle weakness and fatigue in geriatric patients. Exp Gerontol. 2012 Jan;47(1):52-9. doi: 10.1016/j.exger.2011.10.005. Epub 2011 Oct 18.
- Background: PubMed 34251390Schettini IVG, Faria DV, Nogueira LS, Otoni A, Silva ACSE, Rios DRA. Renin angiotensin system molecules and chemokine (C-C motif) ligand 2 (CCL2) in chronic kidney disease patients. J Bras Nefrol. 2022 Jan-Mar;44(1):19-25. doi: 10.1590/2175-8239-JBN-2021-0030.
- Background: PubMed 31474705Watanabe H, Enoki Y, Maruyama T. Sarcopenia in Chronic Kidney Disease: Factors, Mechanisms, and Therapeutic Interventions. Biol Pharm Bull. 2019;42(9):1437-1445. doi: 10.1248/bpb.b19-00513.
- Background: PubMed 39973319Chao CT, Kovesdy CP, Merchant RA. Sarcopenia, sarcopenic obesity, and frailty in individuals with chronic kidney disease: a comprehensive review. Kidney Res Clin Pract. 2026 Mar;45(2):174-188. doi: 10.23876/j.krcp.24.207. Epub 2025 Jan 21.
- Background: PubMed 24981816Wang XH, Mitch WE. Mechanisms of muscle wasting in chronic kidney disease. Nat Rev Nephrol. 2014 Sep;10(9):504-16. doi: 10.1038/nrneph.2014.112. Epub 2014 Jul 1.
- Background: PubMed 30675426Bello AK, Alrukhaimi M, Ashuntantang GE, Basnet S, Rotter RC, Douthat WG, Kazancioglu R, Kottgen A, Nangaku M, Powe NR, White SL, Wheeler DC, Moe O. Complications of chronic kidney disease: current state, knowledge gaps, and strategy for action. Kidney Int Suppl (2011). 2017 Oct;7(2):122-129. doi: 10.1016/j.kisu.2017.07.007. Epub 2017 Sep 20.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Abdominal Muscles/Ultrasonography, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonography measurements (time frame: 20 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07854275, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.